Application 211783

Type: ANDA
Sponsor: CHEMO RESEARCH SL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1%	No	No
002	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (0.5GM/PACKET)	No	No
003	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (1GM/PACKET)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211783-001	ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10
A211783-002	ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10
A211783-003	ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211783-001	AB
A211783-002	AB
A211783-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211783-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211783-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211783-003	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2022-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211783-001	ESTRADIOL	0.1%	GEL / TRANSDERMAL	AB	2022-08-10	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211783-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211783-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211783-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211783-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211783-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211783-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211783-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211783-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211783-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211783-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211783-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211783-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211783-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211783-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211783-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211783-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211783-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211783-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211783-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211783-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211783-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211783-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211783-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211783-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211783-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211783-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211783-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211783-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211783-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211783-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211783-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211783-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211783-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211783-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211783-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211783-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211783-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211783-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211783-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211783-001	AB	1	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A211783-001	CGT	2023-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211783-001	CGT	2023-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211783-001	CGT	2023-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211783-001	CGT	2023-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211783-001	CGT	2023-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211783-001	CGT	2023-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211783-001	CGT	2023-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211783-001	CGT	2023-04-08	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL GEL 0.1%	Xiromed, LLC	1a46efe6-21b9-3f0f-90b9-59f279ef51df	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211783 application number: ANDA211783 ndc (product): 70700-144 ndc (product): 70700-194 ndc (product): 70700-143 ndc (product): 70700-145 ndc (product): 70700-195

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70700-143	Estradiol	Estradiol Gel 0.1%	Xiromed, LLC	ANDA	Current
70700-144	Estradiol	Estradiol Gel 0.1%	Xiromed, LLC	ANDA	Current
70700-145	Estradiol	Estradiol Gel 0.1%	Xiromed, LLC	ANDA	Current
70700-194	Estradiol	Estradiol Gel 0.1%	Xiromed, LLC	ANDA	Current
70700-195	Estradiol	Estradiol Gel 0.1%	Xiromed, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72028	ORIG	2022-09-07